Fosamax, Other Osteoporosis Drugs Need Stronger Warnings, FDA Advisors Say

A panel of Food & Drug Administration (FDA) advisors said on Friday that <"">Fosamax and similar bone drugs need stronger warnings regarding duration of use because of their possible long-term risks. But the panel could not agree if use of the drugs, known as oral bisphosphonates, should be limited to five years, or how new warnings should be worded.

Oral bisphosphonates like Fosamax, <"">Reclast, <"">Actonel and <"">Boniva are taken by more than 5 million Americans every year, most of whom are post-menopausal women taking them to prevent or treat osteoporosis. However, few studies have been conducted to assess the drugs’ long-term risks.

Over the past several years, concerns have grown that taking bisphosphonates indefinitely could put women at risk of serious side effects. In 2005, the FDA ordered that the labels for bisphosphonates be updated to include warnings about osteonecrosis of the jaw, a condition also known as dead jaw syndrome. Last year, warnings were added to the “Warnings and Precautions” section regarding their association with atypical femur fractures. The FDA is currently reviewing a possible link between bisphosphonates and esophageal cancer.

Last week, a report issued by FDA staff said that women who need bisphosphonates to treat or prevent osteoporosis may only need to take the drugs for five years. According to the 45-page report, studies “suggest no significant advantage of continuing drug therapy beyond five years.”

On Friday, the agency conducted a joint meeting of its Drug Safety and Risk Management Committee and the Advisory Committee for Reproductive Health Drugs to discuss the long-term risks of oral bisphosphonates. According to The New York Times, the panel remembers voted 17-6 that the drugs’ labels should be updated to “further clarify the duration of use.” The panel left how those warnings should be worded up to the FDA

None of the panel members recommended firm time limits for the drugs, or the addition of a Black Box warning for their labels.

Patient advocates were less than pleased with the outcome. Dr. Lewis S. Nelson, a toxicologist with the New York University School of Medicine and chairman of the F.D.A. Drug Safety and Risk Management Committee, said evidence warranted “something a little bit more dramatic,” according to the Times. Others had sought stronger language asking doctors to review a patient’s use of the drug annually.

According to a report from MedPage Today, the FDA advisors backed away from recommending specific time limits due to a lack of data to “pinpoint an ideal therapeutic time limit.”

The panel was also asked to discuss the idea of a patients being prescribed a drug holiday”, or a temporary break, from taking bisphosphonates to minimize their risks, but agreed the was not enough evidence to recommend that route.

During the panel meeting on Friday, the FDA advisors heard from women who have suffered suspected bisphosphonate side effects. According to The Wall Street Journal, women who suffered thigh fractures described their legs literally collapsing after simply taking a step. X-rays showed bone breaks more typical of those seen from car crashes.

According to The New York Times, the FDA is expected to issue an updated label for oral bisphosphonates in November. The FDA is not legally bound to follow the recommendations of its advisory panels, but in most cases it does so.

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